Session on Pharmacovigilance - 24.10.2013

Location: De Montil, Affligem


Programme and Speakers:

13:30 Session introduction
Noëlla Heyman, BRAS Education Group

13:35 Implementation of Directive 2010/84/EU and Regulation (EU) 1235/2010
Thierry Roisin, AFMPS//FAGG (FR)

• Royal Decree of 14 December 2006, as amended by the Royal Decree of 28 May 2013
• Summary of main changes
• New Circular of the AFMPS/FAGG

14:00 Individual Case Safety Reports: Flow of the spontaneous reports of suspected adverse drugs from health care professionals and consumers & Medication errors
Goedele Alaerts (NL) / Olivier Bouffioux (FR), AFMHP/FAGG

14:25 Signal Detection

14:35 PSUR (PBRER)
Laurence  de Fays, AFMPS/FAGG (FR)

15:05 Coffee break

15:35 National implementation of measures taken at EU level
Katrien Bernaert, AFMPS//FAGG (NL)

15:50 PSMF and local requirements
Nele Matthijs, AFMPS-FAGG (DG Inspection) (ENG)

16:25 Private law aspects related to pharmacovigilance:
a) the impact of pharmacovigilance on product liability
b) contractual provisions on pharmacovigilance
Annabelle Bruyndonckx and Olivier Mignolet, Simmons & Simmons (ENG)

16:55 Questions & Answers
Annabelle Bruyndonckx/Noëlla Heyman

17:25 End of session
Annabelle Bruyndonckx

Practical aspects: slides in English ; session in French (FR), Dutch (NL) and English (ENG)

Fees: 150€ for BRAS members - 350€ for non BRAS members
It is understood, to be admitted to the session, that the fees have been pre-paid. In case of cancellation after 14 October 2013, the fees are due and will be invoiced.


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